Although the GDS Policy will apply also to Research and Development (R&D) contracts and NIH intramural projects that involve the generation of large-scale, human and/or non-human genomic data, this Notice only applies to implementation of the GDS Policy for NIH extramural grant activities. Guidance applicable to R&D contract offers will be incorporated into the appropriate Requests for Proposals.

Funding Activities
The GDS Policy has no direct cost threshold associated with it and applies only to grant activities requesting support for research, such as:

Research project grants (Rs);

Program projects (Ps) and SCORs (Ss);

Cooperative agreements for research (Us);

Individual career development awards (Ks) that include a research component;

Facilities or coordinating centers funded through related initiatives to provide genotyping, sequencing, or other core services in support of GDS.

Grant Applications
Applicants preparing grant applications are expected to state in the cover letter that the studies proposed will generate large-scale human and/or non-human genomic data. Applications proposing such research are expected to include a genomic data sharing plan. In situations where the sharing of human data is not possible (i.e., the Institutional Certification criteria cannot be met), applicants should provide a justification explaining why they cannot share these data and provide an alternative data sharing plan. Exceptions to NIH expectations for data submission to an NIH-designated data repository will be considered on a case-by-case basis by the NIH funding Institute or Center (IC).

Applicants who wish to use controlled-access human genomic data from NIH-designated data repositories (e.g., dbGaP) as a secondary user to achieve the specific aim(s) of the research proposed in the grant application should briefly address their plans for requesting access to the data and state their intention to abide by the NIH Genomic Data User Code of Conduct in the Research Plan of the application. Applicants should be aware that access to these data is dependent on an approval process that involves the relevant NIH Data Access Committee(s). Applicants may wish to secure access to the data prior to submitting their application for NIH support. Secondary users of controlled-access data are not expected to deposit their findings into NIH-designated data repositories, unless appropriate.

Peer Review
During peer review, reviewers will be asked to comment on the genomic data sharing plan but will not factor the plan into the Overall Impact score, unless specified in the Funding Opportunity Announcement. After initial peer review, NIH Program Officers may accept the plan as provided, recommend changes to the applicant, or request additional information.

Institutional Certification for Human Genomic Data
With implementation of the GDS Policy, submission of the Institutional Certification for human genomic data will become part of the NIH grant application process. The authorized Institutional Official of the institution submitting the application should provide the Institutional Certification to assure that the proposal for data submission and sharing is consistent with appropriate laws and regulations, and to delineate the appropriate research uses of the data. Following initial peer review and prior to award, potential grantee institutions will be asked to submit an Institutional Certification through the standard Just-in-Time process.

Transition Provisions for Research Funded Before the Effective Date of the Policy
Although the GDS Policy does not apply to research submitted prior to the Policy’s effective date, NIH, nonetheless, strongly encourages investigators to comply with the expectations outlined in the Policy. Investigators should provide an updated genomic data sharing plan to the funding IC in the submission of the research performance progress report. For studies involving human participants that were initiated before the Policy’s effective date and used consents that do not meet the expectations of the GDS Policy, investigators are expected to plan to transition to a consent for future research uses and broad sharing, if possible, particularly for new or additional collections of specimens. There will be reasonable accommodation, determined on a case-by-case basis by the funding IC, for long-term projects ongoing at the time of the Policy’s effective date to come into alignment with NIH’s expectations for consent and data sharing. The goal is to bring these projects into alignment, to the extent possible, in a reasonable timeframe.

Notice of Award
If the grant is funded, the resource sharing plan, including the genomic data sharing plan, will be referenced as a Special Term and Condition on the Notice of Award. Failure to comply with the special award term and condition may result in an enforcement action as outlined in the NIH Grants Policy Statement Section 8.5, Special Award Conditions and Enforcement Actions” available at http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch8.htm#_Toc271264977.